PROPONENT DR SL (Model L201)
Pending LLM rewrite. Source: FDA_DEVICE Z-0086-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
The recalled product
- Product
- PROPONENT DR SL (Model L201)
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- GTIN 00802526559044
- Serial Numbers: 760356
- 760366
- 760367
- 760404
- 760409
- 760412
- 760441
- 760443
- 760500. GTIN 00802526576379
- Serial numbers: 767280. GTIN 00802526559051
- Serial numbers: 767088
- 799586. GTIN 00802526576379
- Serial Numbers: 100164
- 100165
- 100174
- 100186
- 100243
- 100767
- 100800
Distribution
Distribution scope not specified by the agency.
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